Pyrotinib Plus Trastuzumab Versus Pertuzumab Plus Trastuzumab

February 23, 2024 updated by: Biyun Wang, MD, Fudan University

Pyrotinib Plus Trastuzumab Versus Pertuzumab Plus Trastuzumab in HER2-Positive Metastatic Breast Cancer: a Multicenter, Retrospective Study

Pyrotinib Plus Trastuzumab Versus Pertuzumab Plus Trastuzumab

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a retrospective study aiming to explore the efficacy and safety of Pyrotinib Plus Trastuzumab Versus Pertuzumab Plus Trastuzumab in patients with HER2-positive metastatic breast cancer.

Study Type

Observational

Enrollment (Actual)

333

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with breast cancer (according to ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage

Description

Inclusion Criteria:

  • HER2+ MBC patients scored +3 by immunohistochemical (IHC) analysis or scored +2 and the result of fluorescence in situ hybridization was positive.
  • Patients received Pyrotinib(320-400 mg, po, qd) plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w) or Pertuzumab(840mg q3w, and then 420 mg q3w) plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w) for at least one cycle, starting from Jan 2018 to Sep 2022.
  • Patients had complete medical records. All data were retrospectively collected from medical records of individual institutions.

Exclusion Criteria:

  • Incomplete medical history

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PyroH
treatment based on Pyrotinib(320-400 mg, po, qd) Plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w)
Drug: Pyrotinib Plus Trastuzumab
treatment based on Pyrotinib(320-400 mg, po, qd) Plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w)
PertH
treatment based on Pertuzumab(840mg q3w, and then 420 mg q3w) Plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w)
Drug: Pertuzumab Plus Trastuzumab
treatment based on Pertuzumab(840mg q3w, and then 420 mg q3w) Plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 6 weeks
Progression free survival
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 6 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Actual)

September 1, 2023

Study Completion (Actual)

September 1, 2023

Study Registration Dates

First Submitted

October 5, 2022

First Submitted That Met QC Criteria

October 5, 2022

First Posted (Actual)

October 10, 2022

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YOUNGBC-21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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